An Open-Label, Two-Cohort, Pharmacokinetic Study in a Maximal Use Setting for Patients With Actinic Keratosis on the Upper Extremities or the Face

Part of paid clinical trials in College Station, Texas.

Sponsor
Sun Pharmaceutical Industries Limited
Study ID
NCT07729579
Phase
PHASE1
Status
Recruiting
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Conditions

  • Actinic Keratosis (AK)

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Investigational drug — DRUG
    The study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.
  • Photodynamic therapy — DEVICE
    The study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.

Study Details

The research study will evaluate how the body absorbs and reacts to reformulated Levulan Kerastick when applied to actinic keratosis lesions (AKs) on the skin of the forearms or face followed by photodynamic therapy (PDT), a treatment that uses application of blue light.

Key Dates

First listed
Jul 27, 2026
Start date
Aug 4, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A or B
    Participants will be enrolled into one of two cohorts depending on the location of the AK lesions, either the face/forehead, or the upper extremities.

Primary Outcome Measure

Plasma concentrations [ Time Frame: From treatment to 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
J&S StudiesCollege StationTexas77845
Brent Clary
[email protected]
979-774-5933

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J&S Studies· College Station, TX

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